Clinical Trials

The Cotton-O'Neil Cancer Center has a comprehensive research program which provides new and exciting therapeutics to patients with cancer. To learn more about our open clinical trials, please review the following sections.

B-42(CTSU)

Activation Date: 04/07/2006

A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer.

Treatment: AI vs Placebo

NSABP B-43

Activation Date: 11/22/2008

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy

Treatment: Radiation Therapy, Trastuzumab

C40101(CTSU)

Activation Date: 6/15/2002

Cyclophosphamide and Doxorubicin (CA) (4 Cycles) Versus Paclitaxel (4 Cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A Phase III Randomized Study

Treatment: Cyclophosphamide, Doxorubicin, and Paclitaxel

C40302(CTSU)

Activation Date: 9/22/2006

Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial for Postmenopausal Women with Estrogen-Receptor Positive Advanced Breast Cancer

Treatment: Fulvastrant, Lapatinib, Placebol

C40502

Activation Date: 10/10/2008

A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound (Nab)-Paclitaxel or Ixabepilone Combined with Bevacizumab as First or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.

Treatment: Paclitaxel, Bevacizumab, Nab-paclitaxel, Ixabepilone

C40503(CTSU)

Activation Date: 5/18/2008

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer

Treatment: Oral Endocrine Agent +/- Bevacizumab

E1105

Activation Date: 11/09/2007

A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-expressing Metastatic Breast Cancer

Treatment: Taxol, +/- Carboplatin, Trastuzumab, +/- Bevacizumab

E5103(CTSU)

Activation Date: 11/02/2007

A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer

Treatment: TAC with or without Bevacizumab

ECOG PACCT-1 (CTSU)

Activation Date: 05/01/2006

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial

Disease Committee: Breast Cancer, Committee on Special Populations

IBCSG-24-02 (CTSU)

Activation Date: 8/15/2003

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenapausal Women with Endocrine Responsive Breast Cancer (SOFT)

Treatment: Exemestane

Click here to apply for this clinical trial.

IBCSG-25-02 (CTSU)

Activation Date: 8/4/2003

A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenapausal Women with Endocrine Responsive Breast Cancer (TEXT)

Treatment: Exemestane and Triptorelin

MA.17R

Activation Date: 11/15/1998

A Phase III Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor either as Initial Therapy or After Tamoxifen (Including those in the MA.17 Study)

Treatment: Letrozole vs Placebo

N063D

Activation Date: 2/15/2008

ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study: A Randomized, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer

Treatment: Lapatinib, Trastuzumab

N0733

Activation Date: 7/30/2008

Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 in Patients with HER2 Positive Breast Cancer Previously Treated with Trastuzumab and an Anthracycline and/or a Taxane

Treatment: IMC-A12, Xeloda, Tykerb

NOVARTIS CZOL446E2352-OPITMIZE 2 Trial

Breast Cancer

Activation Date: 03/06/2006

A prospective, randomized, double-blind, stratified, placebo-controlled, multi-center, 3-arm trial of the continued efficacy and safety of Zometa (every 4 weeks vs. every 12 weeks vs. placebo) in patients with documented bone metastases from breast cancer.

Treatment: Zometa vs Placebo

S0221

Activation Date: 11/1/2003

Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High -Risk Node Negative Breast Cancer

Treatment: Adriamycin + Cytoxan every 2 wks vs. Adriamycin every week +Cytoxan daily by mouth followed by Paclitaxel every week vs. every 2 weeks (2x2 factorial 4 arms)

S0226

Activation Date: 04/01/2004

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

Treatment: Anastrozole, Fulvestrant

S0230

Activation Date: 10/01/2003

Phase III Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

Treatment: Goserelin acetate, Surgery

S0307

Activation Date: 11/15/2005

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

Treatment: Clodronate, Zoledronic Acid, Ibandronate

S0500

Activation Date: 10/01/2006

A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

Treatment: CellSearch Assay

Click here to apply for this clinical trial.

S0000A

Activation Date: 5/17/2002

PREADVISE, Prevention of Alzheimer's Disease with Vitamin E and Selenium, Phase III Ancillary to S0000 - SELECT

Treatment: Vitamin E, Selenium

S0000B

Activation Date: 7/1/2004

Phase III Prevention of Cataract and Age-Related Macular Degeneration with Vitamin E and Selenium - SELECT Eye Endpoints (SEE)

Treatment: Selenium, Vitamin E

C80101 (CTSU)

Activation Date: 3/15/2003

Phase III Intergroup Trial of Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma

Treatment: 5-Fluorouracil, Leucovorin Calcium, Cisplatin, Epirubicin, Radiation Therapy

C80405 (CTSU)

Activation Date: 10/01/2005

A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

Treatment: Irinotecan, Leucovorin + 5-FU, Oxaliplatin, Bevacizumab, Cetuximab

E5202 (CTSU)

Activation Date: 08/04/2005

A Randomized Phase III Study Comparing 5-FU, Leucovorin, and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

Treatment: 5FU, Leucovorin, Oxaliplatin and Bevacizumab

E5204 (CTSU)

Activation Date: 04/15/2006

Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation

Treatment: Leucovorin + 5-FU, Oxaliplatin, Bevacizumab

NO147 (CTSU)

Activation Date: 2/10/2004

A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

Treatment: Oxaliplatin, 5-fluorouracil, Leucovorin, Irinotecan

NSABP R-04 (CTSU)

Activation Date: 4/162006

Phase III Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum

Treatment: Capecitabine, 5-Fluorouracil, Oxaliplatin, Radiation Therapy

S0518

Activation Date: 12/01/2007

Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients

Treatment: Bevacizumab, Interferon alpha-2b, Octreotide acetate for injectable suspension

S0600

Activation Date: 6/15/2007

Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) with or without Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with FOLFOX, OPTIMOX, or XELOX

Treatment: Bevacizumab, 5-Fluorouracil, Cetuximab, Irinotecan, Leucovorin Calcium

C90202 (CTSU)

Activation Date: 08/01/2004

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

Treatment: Zoledronic Acid

E2804 (CTSU)

Activation Date: 9/14/2007

The BeST Trial: A Randomized Phase II study of VEGF, RAF Kinase, mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib, Temsirolimus in Advanced Renal Cell Carcinoma

Treatment: Bevacizumab, Sorafenib, Temsirolimus

E2805 (CTSU)

Activation Date: 05/08/2006

A Randomized, Double Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma

Treatment: Sunitinib, Sorafenib, Placebo

S0421

Activation Date: 08/21/2006

Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer

Treatment: Docetaxel, Atrasentan, Docetaxel and Placebo

GOG-0209 (CTSU)

Activation Date: 08/18/2003

A Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF versus Carboplatin/Paclitaxel in Patients with Stage III & IV or Recurrent Endometrial Cancer

Treatment: Doxorubicin/Cisplatin/Paclitaxel and G-CSF

GOG-0218 (CTSU)

Activation Date: 09/26/2005

A Phase III Trial Of Carboplatin And Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed By Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent And Extended Bevacizumab, In Women With Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer

Treatment: Carboplatin, Paclitaxel, Bevacizumab, Placebo

E1305 (CTSU)

Activation Date: 08/08/2008

A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab In Patients with Recurrent Or Metastatic Head and Neck Cancer

Treatment: Cisplatin, Bevacizumab

RTOG 0522 (CTSU)

Activation Date: 12/08/2005

A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

Treatment: Cisplatin, Radiotherapy, Cetuximab, Surgery

C10403 (SWOG Intergroup)

Activation Date: 01/15/2008

Status Notes: Please note that in addition to the specimen submission requirements outlined in the protocol, a separate submission for FISH analysis is required for all SWOG patients as outlined in the Activation Memorandum.
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)

Treatment: Allopurinol, Trimethoprim sulfa, Cytosine Arabinoside, Cyclophosphamide, Daunomycin, Dexamethasone, Doxorubicin, Leucovorin Calcium, 6-Mercaptopurine, Methotrexate, PEG-L-Asparaginase, 6-Thioguanine, Vincristine

CALGB-10501

Activation Date: 01/15/2008

A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation with Later Treatment in the High-Risk Genetic Subset with IGVH Unmutated Disease

Treatment: Rituxin, Fludara, Observation

E1905 – (SWOG Intergroup)

Activation Date: 10/01/2006

A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia with Multilineage Dysplasia

Treatment: Azacitidine, MS-275

E2902 (CTSU)

Activation Date: 08/18/2004

A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission after Primary Induction Failure or Patients over Age 60 in First Remission

Treatment: R115777

S9910

Activation Date: 7/15/2000

Leukemia Centralized Reference Laboratories and Tissue Repositories

Treatment: Ancillary

S0106

Activation Date: May 15, 2004

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (MylotargÆ) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (MylotargÆ) or No Additional Therapy for Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)

Treatment: Cytosine Arabinoside, Daunomycin, Gemtuzumab Ozogamicin, rhGM-CSF, G-CSF

S0325

Activation Date: 08/15/2004

A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.

Treatment: STI-571/Imatinib

S0703

Activation Date: 12/01/2008

A Phase II Trial of Azacitidine plus Gemtuxumab Ozogamicin as Induction and Post-Remission Therapy in Older Patiest with Previously Undtreated Non-M3 Myeloid Leukemia

Treatment: Hydroxyures, Azacitidine, Gemtuzumab Ozogamicin

CALGB-30607

Activation: 05/15/2008

Randomized, Phase III, Placebo-Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer

Treatment: Sunitinib, Placebo

E1505

Activation: 12/20/2005

A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

Treatment: Choice of 3 different regiments +/- Bevacizumab

E5597

Activation Date: 10/06/2000

A Phase III chemoprevention trial of Selenium supplementation in persons with resected stage I non-small cell lung cancer.

Treatment: Selenium

N0723

Activation Date: 10/01/2008

MARVEL: Marker Validation of Erlotinib in Lung Cancer - A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib

Treatment: Pemetrexed, Erlotinib

S0424

Activation Date: 10/01/2005

Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men

Treatment: Ancillary

S0429

Activation Date: 04/01/2006

A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer

Treatment: Cetuximab, Docetaxel, Radiation Therapy

S0635

Activation Date: 07/15/2007

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features

Treatment: OSI-774, Bevacizumab

S0636

Activation Date: 07/15/2007

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas

Treatment: Bevacizumab, OSI-774

S0709

Activation Date: 12/01/2008

A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib) or OSI-744 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performace Status 2 (PS-2) Selected by Serum Proteomics

Treatment: Carboplatin, Paclitaxel, OSI-774

S9925

Activation Date: 9/1/2000

Lung Cancer Specimen Repository Protocol

Treatment: Ancillary

Activation Date: 09/15/2006

A Phase III Randomized Study of R-CHOP v. Dose-adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

Treatment: CHOP, Etoposide, Vincristine, Doxorubicin, Prednisone, Cyclophosphamide, Rituximab

E1A02

Lymphoma

Activation Date: 7/15/2004

Phase II Pilot Study of Rituximab + CHOP in Patients with Newly Diagnosed Waldenstrom's Macroglobulinemia

Treatment: CHOP, Rituximab

Click here to apply for this clinical trial.

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S8819

Lymphoma

Activation Date: 2/15/1989

Central Lymphoma Repository Tissue Procurement Protocol

Treatment: Ancillary

Click here to apply for this clinical trial.

S8947

Lymphoma

Activation Date: 4/15/1990

Central Lymphoma Serum Repository Protocol

Treatment: Ancillary

Click here to apply for this clinical trial.

S9245

Lymphoma

Activation Date: 3/15/1993

Central Lymphoma Repository Tissue Procurement Protocol for Relapse or Recurrent Disease

Treatment: Ancillary

Click here to apply for this clinical trial.

S0350

Lymphoma

Activation Date: 09/15/2005

Phase II Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma

Treatment: Cisplatin, Etoposide, Gemcitabine, Methyl Prednisolone

Click here to apply for this clinical trial.

S0801

Lymphoma

Activation Date: Not open for enrollment

A Phase II Study of Iodine-131 Labeled Tositumomab in Combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients with Advanced Stage Follicular Non-Hodgkinís Lymphoma

Treatment: CHOP, Tositumomab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Click here to apply for this clinical trial.

E1697

Melanoma

Activation Date: 10/15/2002

Phase III Randomized Study of Four Weeks High Dose IFN- 2b in Stage T2b No, T3a-b, T4a-b No, and T1-4, N1a, 2a, 3 (microscopic) Melanoma

Treatment: Interferon-alpha2b, Surgery

Click here to apply for this clinical trial.

S0438

Melanoma

Activation Date: 08/01/2007

A Randomized Phase II Trial of BAY 43-9006 (Sorafenib) with Either CCI-779 (Temsirolimus) or R115777 (Tipifarnib) in Metastatic Melanoma

Treatment: BAY 43-9006, CCI-779, R115777

Click here to apply for this clinical trial.

E1A06

Myeloma

Activation Date: 02/28/2008

An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(tm)) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Treatment: Melphalan, Prednisone, Thalidomide, Lenalidomide

Click here to apply for this clinical trial.

S0120

Myeloma

Activation Date: 6/1/2002

A Prospective Observational Biologic Study of Asymptomatic Patients with Monoclonal Gammopathy and Plasmaproliferative Disorders

Treatment: Biologic

Click here to apply for this clinical trial.

S0309

Myeloma

Activation Date: 11/15/2003

Ancillary Myeloma Specimen Repository Protocol

Treatment: Ancillary

Click here to apply for this clinical trial.

S0777

Myeloma

Activation Date: 04/01/2008

A Randomized Phase III Trial of CC-5-13 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant

Treatment: CC-5013 (Lenalidomide), Dexamethasone, Bortezomib, Cyclophosphamide, Filgrastim, GM-CSF

Click here to apply for this clinical trial.

SZ9001 (CTSU)

Sarcoma

Activation Date: 10/1/2002

A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec TM) versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)

Treatment: STI-571/Imatinib

Click here to apply for this clinical trial.